Trial Outcomes & Findings for Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide (NCT NCT02170519)
NCT ID: NCT02170519
Last Updated: 2024-10-15
Results Overview
Readings were taken from the medical record and the data may not have been present at the exact time frames.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Phase 2: Inhaled Iloprost Continuous
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
5
|
|
Overall Study
COMPLETED
|
22
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Baseline characteristics by cohort
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=22 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>18 years
|
21 participants
n=5 Participants
|
5 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Age, Customized
<=18 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
5 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursPopulation: Phase 2 subjects
Readings were taken from the medical record and the data may not have been present at the exact time frames.
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=22 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
30 mins after initial dose
|
-0.4 percent change
Standard Deviation 1.7
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
2 hours
|
-0.8 percent change
Standard Deviation 2.8
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
4 hours
|
-1.2 percent change
Standard Deviation 2.9
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
6 hours
|
-0.2 percent change
Standard Deviation 3.6
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
8 hours
|
-0.7 percent change
Standard Deviation 3.1
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
10 hours
|
-0.9 percent change
Standard Deviation 3.0
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
12 hours
|
-0.9 percent change
Standard Deviation 3.7
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
18 hours
|
-1.5 percent change
Standard Deviation 5.6
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
24 hours
|
1.7 percent change
Standard Deviation 6.4
|
—
|
PRIMARY outcome
Timeframe: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)Population: Phase 1 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
combined therapy
|
0.2 percent change
Standard Deviation 2.4
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
dose 1
|
-0.4 percent change
Standard Deviation 0.6
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
dose 2
|
-0.4 percent change
Standard Deviation 1.6
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
dose 3
|
0.0 percent change
Standard Deviation 2.9
|
—
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
end INO
|
0.4 percent change
Standard Deviation 1.6
|
—
|
PRIMARY outcome
Timeframe: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursPopulation: Phase 2 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=22 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Mean Heart Rate From Baseline
2 hours
|
-1.1 percent change
Standard Deviation 6.6
|
—
|
|
Change in Mean Heart Rate From Baseline
30 mins after initial dose
|
-1.8 percent change
Standard Deviation 4.4
|
—
|
|
Change in Mean Heart Rate From Baseline
4 hours
|
4.2 percent change
Standard Deviation 18.7
|
—
|
|
Change in Mean Heart Rate From Baseline
6 hours
|
0.8 percent change
Standard Deviation 12.5
|
—
|
|
Change in Mean Heart Rate From Baseline
8 hours
|
-1.0 percent change
Standard Deviation 13.7
|
—
|
|
Change in Mean Heart Rate From Baseline
10 hours
|
2.2 percent change
Standard Deviation 14.3
|
—
|
|
Change in Mean Heart Rate From Baseline
12 hours
|
-2.9 percent change
Standard Deviation 12.0
|
—
|
|
Change in Mean Heart Rate From Baseline
18 hours
|
-4.0 percent change
Standard Deviation 12.6
|
—
|
|
Change in Mean Heart Rate From Baseline
24 hours
|
-9.9 percent change
Standard Deviation 16.1
|
—
|
PRIMARY outcome
Timeframe: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)Population: Phase 1 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Mean Heart Rate From Baseline
dose 1
|
0.9 percent change
Standard Deviation 4.8
|
—
|
|
Change in Mean Heart Rate From Baseline
dose 2
|
2.5 percent change
Standard Deviation 4.5
|
—
|
|
Change in Mean Heart Rate From Baseline
dose 3
|
0.7 percent change
Standard Deviation 6.7
|
—
|
|
Change in Mean Heart Rate From Baseline
combined therapy
|
0.9 percent change
Standard Deviation 7.8
|
—
|
|
Change in Mean Heart Rate From Baseline
end INO
|
-0.2 percent change
Standard Deviation 8.9
|
—
|
PRIMARY outcome
Timeframe: as long as subject was on drug up to approximately 24 hoursTreatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=22 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Number of Treatment Failures
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursPopulation: Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=18 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
30 mins after initial dose
|
1.9 percent change
Standard Deviation 9.6
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
2 hours
|
-1.1 percent change
Standard Deviation 19.1
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
4 hours
|
3.1 percent change
Standard Deviation 17.2
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
6 hours
|
-1.9 percent change
Standard Deviation 16.9
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
8 hours
|
-3.2 percent change
Standard Deviation 20.4
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
10 hours
|
1.6 percent change
Standard Deviation 12.7
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
12 hours
|
1.3 percent change
Standard Deviation 15.7
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
18 hours
|
6.5 percent change
Standard Deviation 17.1
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
24 hours
|
7.0 percent change
Standard Deviation 23.5
|
—
|
PRIMARY outcome
Timeframe: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)Population: Phase 1 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
dose 1
|
-0.9 percent change
Standard Deviation 10
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
dose 2
|
-6.5 percent change
Standard Deviation 10.9
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
dose 3
|
-10.2 percent change
Standard Deviation 8.6
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
combined therapy
|
-13.0 percent change
Standard Deviation 9.6
|
—
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
end INO
|
-9.3 percent change
Standard Deviation 12.9
|
—
|
SECONDARY outcome
Timeframe: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursPopulation: Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=17 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Cardiac Output (CO) From Baseline
30 mins after initial dose
|
16.2 percent change
Standard Deviation 25.6
|
—
|
|
Change in Cardiac Output (CO) From Baseline
2 hours
|
3.4 percent change
Standard Deviation 20.5
|
—
|
|
Change in Cardiac Output (CO) From Baseline
4 hours
|
21.2 percent change
Standard Deviation 31.1
|
—
|
|
Change in Cardiac Output (CO) From Baseline
6 hours
|
14.3 percent change
Standard Deviation 43.1
|
—
|
|
Change in Cardiac Output (CO) From Baseline
8 hours
|
12.5 percent change
Standard Deviation 55.1
|
—
|
|
Change in Cardiac Output (CO) From Baseline
10 hours
|
9.3 percent change
Standard Deviation 43.3
|
—
|
|
Change in Cardiac Output (CO) From Baseline
12 hours
|
8.9 percent change
Standard Deviation 38.8
|
—
|
|
Change in Cardiac Output (CO) From Baseline
18 hours
|
36.6 percent change
Standard Deviation 68.9
|
—
|
|
Change in Cardiac Output (CO) From Baseline
24 hours
|
4.4 percent change
Standard Deviation 27.9
|
—
|
SECONDARY outcome
Timeframe: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)Population: Phase 1 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Cardiac Output (CO) From Baseline
dose 1
|
8.4 percent change
Standard Deviation 33.7
|
—
|
|
Change in Cardiac Output (CO) From Baseline
dose 2
|
-0.9 percent change
Standard Deviation 36.3
|
—
|
|
Change in Cardiac Output (CO) From Baseline
dose 3
|
8.7 percent change
Standard Deviation 18.6
|
—
|
|
Change in Cardiac Output (CO) From Baseline
combined therapy
|
2.5 percent change
Standard Deviation 9.3
|
—
|
|
Change in Cardiac Output (CO) From Baseline
end INO
|
-8.7 percent change
Standard Deviation 20.9
|
—
|
SECONDARY outcome
Timeframe: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursPopulation: Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.
SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=17 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
30 mins after initial dose
|
1.5 percent change
Standard Deviation 8.5
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
2 hours
|
1.5 percent change
Standard Deviation 9.6
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
4 hours
|
1.3 percent change
Standard Deviation 5.1
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
6 hours
|
1.1 percent change
Standard Deviation 7.4
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
8 hours
|
1.4 percent change
Standard Deviation 4.8
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
10 hours
|
-3.4 percent change
Standard Deviation 7.4
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
12 hours
|
-1.6 percent change
Standard Deviation 6.6
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
18 hours
|
-0.5 percent change
Standard Deviation 10.3
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
24 hours
|
-3.0 percent change
Standard Deviation 13.9
|
—
|
SECONDARY outcome
Timeframe: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)Population: Phase 1 subjects
Outcome measures
| Measure |
Phase 2: Inhaled Iloprost Continuous
n=5 Participants
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
Phase 1: Inhaled Iloprost 3 Doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
|
|---|---|---|
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Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
dose 2
|
-2.6 percent change
Standard Deviation 5.5
|
—
|
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Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
dose 3
|
-1.7 percent change
Standard Deviation 7.5
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
dose 1
|
-2.3 percent change
Standard Deviation 2.3
|
—
|
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Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
combined therapy
|
0.3 percent change
Standard Deviation 6.0
|
—
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
end INO
|
1.4 percent change
Standard Deviation 2.0
|
—
|
Adverse Events
Phase 2: Inhaled Iloprost Continuous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1: Inhaled Iloprost 3 Doses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place